The Índigo OPTIMA Laser System with Diffuser-Tip Fiberoptic is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or Jateral lobes ranging in total volume from 20-85 cc; and for general surgery, general urological, general gynecological and general gastroenterological procedures; and coagulative necrosis and interstitial laser coagulation of soft tissues such as tumors and fibroids.

The Indigo OPTIMA Laser System, when used in conjunction with the Bare-Tip Fiberoptic, is indicated for the incision, excision, and ablation or coagulation of tissues with hemostasis during general surgery, and general gastroenterological and urological procedures, including those involving urethral strictures, bladder neck contractures, and condylomata.

Device Description

The Indigo® OPTIMA Laser System consists of a treatment diode laser, fiberoptic energy delivery devices, a footswitch, and an optional cart with printer. The treatment laser allows delivery of controlled doses of laser energy in wavelengths between 800 and 850 nanometers (nm). When used with the OPTIMA Diffuser-Tip Fiberoptic, this laser energy is diffused radially at 360° to the affected tissue to provide interstitial thermotherapy (ITT), or interstitial laser coagulation (ILC). The fiberoptics (fibers) are designed to be sterile, single patient use, disposable devices.

Modifications to design of the Diffuser-Tip Fiberoptic have been made to improve manufacturability. Changes include removal of the inner sleeve, use of a new non patient-contacting adhesive, and a software modification.

AI/ML Overview

The provided text describes a Special 510(k) Premarket Notification for the Índigo® OPTIMA Laser System. This type of submission is for modifications to a previously cleared device, asserting substantial equivalence to the predicate device. Therefore, the focus of the performance data is on demonstrating that the modifications do not raise new questions of safety or effectiveness and that the modified device performs as intended and is equivalent to the predicate.

Based on the provided text, a detailed study with specific acceptance criteria, sample sizes, expert ground truth establishment, or comparative effectiveness with human readers (as would be typical for an AI/ML device) is not applicable here. This document is for a medical device that delivers laser energy, not an AI or imaging diagnostic device.

Here's a breakdown of the information as requested, tailored to the context of this device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Functional Equivalence	Modified Diffuser-Tip Fiberoptic performs as intended and is equivalent to the predicate.	"Design verification and validation testing confirms the modified Diffuser-Tip Fiberoptic performs as intended and is equivalent to the predicate."
Safety	Modifications do not raise new issues of safety.	"No new issues of safety and effectiveness have been raised by these modifications."
Effectiveness	Modifications do not raise new issues of effectiveness.	"No new issues of safety and effectiveness have been raised by these modifications."
Operating Parameters	Adjusted laser operating parameters accommodate design changes with no loss in performance.	"The operating parameters of the laser have been adjusted slightly to accommodate the design changes with no loss in performance."
Intended Use	Device maintains its intended use for treating BPH symptoms.	The intended use statement remains the same as the predicate: "The Indigo OPTIMA Laser System when used with the Diffuser-Tip Fiberoptic is intended for the safe and effective treatment of symptoms of benign prostatic hyperplasia (BPH)."
Technological Characteristics	Technological features remain the same as the predicate, with minor design changes aimed at manufacturability.	"The technological features of the modified Diffuser-Tip Fiberoptic are the same as the predicate with exception of the above design changes." (Changes include removal of inner sleeve, new non-patient contacting adhesive, software modification).

Explanation: In a Special 510(k), the primary "acceptance criterion" is often demonstrating that the modified device is substantially equivalent to the predicate and that the changes do not adversely affect safety or effectiveness. Specific quantitative metrics (e.g., sensitivity, specificity, AUC) typically associated with AI/ML or diagnostic devices are not provided because the device's function is energy delivery for treatment, not diagnostic interpretation.

2. Sample size used for the test set and the data provenance:

Information Not Provided: The submission does not detail specific "test sets" or data provenance in the way an AI/ML device might. The "performance data" refers to "design verification and validation testing." This likely involved engineering bench testing, simulated use, and potentially some animal or cadaver studies, but specifics are not outlined in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Information Not Provided: This concept of "expert ground truth" is not applicable to a laser energy delivery system submission. The "truth" is established through engineering and biological performance verification, not expert interpretation of outputs.

4. Adjudication method for the test set:

Information Not Provided: Not applicable for this type of device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, not done: This is a laser energy delivery system, not an AI-assisted diagnostic or interpretive device. Therefore, MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

N/A: The Indigo® OPTIMA Laser System is a physical medical device operated by a human, not a standalone algorithm.

7. The type of ground truth used:

Engineering Specifications and Biological Performance: The implicit "ground truth" for this device would be its ability to consistently and reliably deliver specific laser energy parameters, achieve the intended thermal effects in tissue, and maintain its sterility and structural integrity as per its design specifications and prior clinical understanding of the predicate device's performance.

8. The sample size for the training set:

Information Not Provided: The concept of a "training set" is not relevant for this hardware device. Design and manufacturing processes are iterative and involve testing, but not in the "training set" context of AI/ML.

9. How the ground truth for the training set was established:

N/A: Not applicable for this device.

Summary of Device Context:

The Índigo® OPTIMA Laser System is a therapeutic device, specifically a laser system for interstitial thermotherapy. The 510(k) submission is for minor modifications to the Diffuser-Tip Fiberoptic (removal of inner sleeve, new adhesive, software modification) aimed at improving manufacturability. The core message is that these changes do not alter the technological features or performance in a way that raises new safety or effectiveness concerns, and the modified device remains substantially equivalent to its predicate. The "performance data" refers to design verification and validation testing demonstrating this equivalence and intended performance.

Summary

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OCT 2 4 2002

K 023182

Ethicon Endo-Surgery, Inc. Special 510(k) Premarket Notification for Índigo® OPTIMA Laser System

Índigo® OPTIMA Laser System 510(k) Summary of Safety & Effectiveness

Company

Contact Carol Sprinkle Regulatory Affairs Specialist

Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242

Date Prepared

September 23, 2002

Name of Device

Trade Name: Índigo® OPTIMA Laser System Classification Name: Laser powered surgical instrument

Predicate Device

İndigo® OPTIMA Laser System (K013493)

Device Description

Intended Use

The Indigo OPTIMA Laser System when used with the Diffuser-Tip Fiberoptic is intended for the safe and effective treatment of symptoms of benign prostatic hyperplasia (BPH).

Comparison of Technological Characteristics

The technological features of the modified Diffuser-Tip Fiberoptic are the same as the predicate with exception of the above design changes. The operating parameters of the laser have been adjusted slightly to accommodate the design changes with no loss in performance. No new issues of safety and effectiveness have been raised by these modifications.

Performance Data

Design verification and validation testing confirms the modified Diffuser-Tip Fiberoptic performs as intended and is equivalent to the predicate.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle, with three curved lines forming its body and wings. The eagle faces to the left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Carol Sprinkle Regulatory Affairs Specialist Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K023182

Trade/Device Name: Indigo® OPTIMA Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology Regulatory Class: Class II Product Code: GEX Dated: September 23, 2002 Received: September 24, 2002

Dear Ms. Sprinkle:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Carol Sprinkle

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

fel Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page __ of

510(k) Number (if known): K023182

Device Name: Índigo® OPTIMA Laser System

Indications for Use:

Miriam C. Provost

eral. Restorative

510(k) Number Ko23182

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Prescription use

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.